510(k) K844183

PALMER OBSTETIC BRACE by Mic Medical Corp. — Product Code KNC

K844183 is an FDA 510(k) premarket notification submitted by Mic Medical Corp. for the device "PALMER OBSTETIC BRACE". The FDA issued a decision of Substantially Equivalent on February 4, 1985. The device falls under product code KNC (Table, Obstetric (And Accessories)), a Class II device regulated under 21 CFR 884.4900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1985
Date Received
October 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Obstetric (And Accessories)
Device Class
Class II
Regulation Number
884.4900
Review Panel
OB
Submission Type